Evaluating the Effective and Safe Use of Stream™ Platform
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFluidAI Medical
About this trial
The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use.
Additionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.
Eligibility criteria
Qualifiers
Age ≥ 18 years - male or female.
Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
Subject underwent colorectal surgery with anastomosis.
Subjects must be willing to comply with trial requirements.
Disqualifiers
Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
24 hours or more have passed since the end of the subject's surgery and consent was not attained.
The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
Plans that the subject will be discharged in less than 3 days post-surgery.
Trial design
Treatments tested in this trial
- Stream™ Platform
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov